Condition category
Cancer
Date applied
31/03/2010
Date assigned
31/03/2010
Last edited
06/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Michelle Harvie

ORCID ID

Contact details

Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5102

Study information

Scientific title

Randomised comparison of three weight control programmes during adjuvant treatment for early breast cancer (Breast - Activity and Healthy Eating After Diagnosis)

Acronym

B- AHEAD

Study hypothesis

To determine whether individualised weight control programmes are better than standard written advice for existing weight and preventing weight gain in first year after breast cancer treatment for women with early breast cancer.

On 06/05/2015 the overall trial end date was changed from 01/12/2010 to 02/02/2012.

Ethics approval

First MREC approval date 09/07/2008 (ref: 08/H1013/45)

Study design

Randomised interventional multicentre process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast

Intervention

Current interventions as of 30/04/2015:
Group 1 (Control): Standard written advice
This group will receive standard written diet and exercise advice.

Group 2 (Intervention): Individualised home-based intervention
Each woman receives individualised diet and exercise advice from the study dietitian (40 minutes) and exercise referral officer (40 minutes). This advice will be reinforced with bi-weekly phone calls (study dietitian) and mailed information during the first 12 weeks, and booster phone calls during the 12-month study.

Group 3 (Intervention): Supervised group community-based weight control programme
Each woman received individualised diet and exercise advice from the study dietitian (40 minutes) and exercise referral officer (40 minutes). They are then asked to attend weekly group classes for the first 12 weeks which comprise an exercise class followed by a diet and behaviour change educational component with handouts, and booster phone calls during the 12-month study.

Previous interventions:
Group 1 (Control): Standard written advice -
This group will receive standard written diet and exercise advice.

Group 2 (Intervention): Individualised home based intervention:
Each woman receives individualised diet and exercise advice from the study dietitian (40 minutes) and exercise referral officer (40 minutes). This advice will be reinforced with bi-weekly phone calls (study dietitian) and mailed information during the first 12 weeks, and booster phone calls during the 12-month study.

Follow Up Length: 12 month(s)
Study Entry: Single Randomisation only

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Changes in body weight and composition (body fat, fat free mass DXA, bioelectrical impedance)

Secondary outcome measures

Uptake and retention to the programmes and any adverse effects of the programmes.

Overall trial start date

11/08/2008

Overall trial end date

02/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Within 10 weeks of primary surgery for primary breast cancer (invasive or in-situ)
2. Pre and postmenopausal women of any age able to undertake interventions
3. Any weight, as programmes aim to tackle existing weight problems and prevent weight gain in healthy weight women
4. Receiving/due to start adjuvant chemotherapy, radiotherapy or endocrine therapy or no adjuvant treatment
5. Early breast cancer stages I - III
6. Ability to understand written instructions and have completed baseline 7 day diet and exercise diaries
7. Resident within Greater Manchester only in order to maximise uptake and retention to interventions and study
8. Written informed consent
9. Females, no specified age limit

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 480; UK Sample Size: 480

Participant exclusion criteria

1. Metastatic or inoperable disease
2. Physical/psychiatric condition which impairs compliance or mobility assessed from medical history by recruitment nurse or verified from baseline fitness assessment by the trial physiotherapist, i.e.:
2.1. Insulin requiring diabetes, as diet and physical activity changes would require close coordination with the treating physician. Non-insulin requiring diabetics are eligible for the study.
2.2. Serious digestive and/or absorptive problems, including inflammatory bowel disease
2.3. Cardiovascular, respiratory (determined from recent pre-operative electrocardiogram [ECG], chest X-ray) disease
2.4. Musculoskeletal disease or joint problems
2.5. Psychiatric disorders or conditions, e.g., untreated major depression, psychosis, substance abuse, severe personality disorder
3. Women who regularly take daily medication known to effect body composition, e.g., corticosteroids (women receiving 2 - 3 days steroids with chemotherapy may be included)
4. Patients with metal implants, ie hip prosthesis are excluded from the study as this precludes DXA measurement of body fat (breast implants, pacemakers are not excluded)
5. Women who have received neoadjuvant chemotherapy or endocrine
6. Patients considering reconstruction surgery in the next 12 months

Recruitment start date

11/08/2008

Recruitment end date

02/02/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of South Manchester NHS Foundation Trust
M23 9LT
United Kingdom

Trial participating centre

The Christie Hospital NHS Trust
M20 4BX
United Kingdom

Trial participating centre

Mid Cheshire NHS Foundation Trust
CW1 4QJ
United Kingdom

Trial participating centre

East Cheshire NHS Trust
SK10 3BL
United Kingdom

Trial participating centre

Pennine Acute Hospitals NHS Trust
M8 5RB
United Kingdom

Trial participating centre

Salford Royal NHS Foundation Trust
M6 8HD
United Kingdom

Trial participating centre

Stockport NHS Foundation Trust
SK2 7JE
United Kingdom

Trial participating centre

Tameside Hospital NHS Foundation Trust
OL6 9RW
United Kingdom

Sponsor information

Organisation

South Manchester University Hospital (UK)

Sponsor details

Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhsm.nhs.uk/Pages/default.aspx

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes